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[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Notices]
[Pages 31359-31361]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12639]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3257-N]

Medicare and Medicaid Programs; Announcement of the Re-Approval 
of the Joint Commission as an Accreditation Organization Under the 
Clinical Laboratory Improvement Amendments of 1988

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the application of the Joint Commission 
for re-approval as an accreditation organization for clinical 
laboratories under the Clinical Laboratory Improvement Amendments of 
1988 (CLIA) program for all specialty and subspecialty areas under 
CLIA. We have determined that the Joint Commission meets or exceeds the 
applicable CLIA requirements. We are announcing the re-approval and 
granting the Joint Commission deeming authority for a period of 6 
years.

DATES: This notice is effective from May 25, 2012 to May 25, 2018.

FOR FURTHER INFORMATION CONTACT: Kathleen Todd, (410) 786-3385.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative Authority

    On October 31, 1988, the Congress enacted the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578). CLIA amended 
section 353 of the Public Health Service Act. We issued a final rule 
implementing the accreditation provisions of CLIA on July 31, 1992 (57 
FR 33992). Under those provisions, we may grant deeming authority to an 
accreditation organization if its requirements for laboratories 
accredited under its program are equal to or more stringent than the 
applicable CLIA program requirements in 42 CFR part 493 (Laboratory 
Requirements). Subpart E of part 493 (Accreditation by a Private, 
Nonprofit Accreditation Organization or Exemption Under an Approved 
State Laboratory Program) specifies the requirements an accreditation 
organization must meet to be approved by CMS as an accreditation 
organization under CLIA.

II. Notice of Approval of the Joint Commission as an Accreditation 
Organization

    In this notice, we approve the Joint Commission as an organization 
that may accredit laboratories for purposes of establishing its 
compliance with CLIA requirements for all specialty and subspecialty 
areas under CLIA. We have examined the initial Joint Commission 
application and all subsequent submissions to determine its 
accreditation program's equivalency with the requirements for approval 
of an accreditation organization under subpart E of part 493. We have 
determined that the Joint Commission meets or exceeds the applicable 
CLIA requirements. We have also determined that the Joint Commission 
will ensure that its accredited laboratories will meet or exceed the 
applicable requirements in subparts H, I, J, K, M, Q, and the 
applicable sections of R. Therefore, we grant the Joint Commission 
approval as an accreditation organization under subpart E of part 493, 
for the period stated in the DATES section of this notice for all 
specialty and subspecialty areas under CLIA. As a result of this 
determination, any laboratory that is accredited by the Joint 
Commission during the time period stated in the DATES section of this 
notice will be deemed to meet the CLIA requirements for the listed 
subspecialties and specialties, and therefore, will generally not be 
subject to routine inspections by a State survey agency to determine 
its compliance with CLIA requirements. The accredited laboratory, 
however, is subject to validation and complaint investigation surveys 
performed by CMS, or its agent(s).

III. Evaluation of the Joint Commission Request for Approval as an 
Accreditation Organization Under CLIA

    The following describes the process used to determine that the 
Joint Commission accreditation program meets the necessary requirements 
to be approved by CMS and that, as such, CMS may approve the Joint 
Commission as an accreditation program with deeming authority under the 
CLIA program. The Joint Commission formally applied to CMS for approval 
as an accreditation organization under CLIA for all specialties and 
subspecialties under CLIA. In reviewing these materials, we reached the 
following determinations for each applicable part of the CLIA 
regulations:

[[Page 31360]]

A. Subpart E--Accreditation by a Private, Nonprofit Accreditation 
Organization or Exemption Under an Approved State Laboratory Program

    The Joint Commission submitted its mechanism for monitoring 
compliance with all requirements equivalent to condition-level 
requirements, a list of all its current laboratories and the expiration 
date of their accreditation, and a detailed comparison of the 
individual accreditation requirements with the comparable condition-
level requirements. The Joint Commission policies and procedures for 
oversight of laboratories performing laboratory testing for all CLIA 
specialties and subspecialties are equivalent to those of CLIA in the 
matters of inspection, monitoring proficiency testing (PT) performance, 
investigating complaints, and making PT information available. The 
Joint Commission's submitted requirements for monitoring and inspecting 
laboratories in the areas of accreditation organization, data 
management, the inspection process, procedures for removal or 
withdrawal of accreditation, notification requirements, and 
accreditation organization resources. The requirements of the 
accreditation programs submitted for approval are equal to or more 
stringent than the requirements of the CLIA regulations.
    Our evaluation identified Joint Commission requirements pertaining 
to waived testing that are more stringent than the CLIA requirements. 
The Joint Commission waived testing requirements include the following:
     Defining the extent that waived test results are used in 
patient care.
     Identifying the personnel responsible for performing and 
supervising waived testing.
     Assuring that personnel performing waived testing have 
adequate, specific training and orientation to perform the testing and 
can demonstrate satisfactory levels of performance.
     Making certain that policies and procedures governing 
waived testing-related procedures are current and readily available.
     Conducting defined quality control checks.
     Maintaining quality control and test records.
    The CLIA requirements at Sec.  493.15 only require that a 
laboratory performing waived testing follow the manufacturer's 
instructions and obtain a certificate of waiver.

B. Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Nonwaived Testing

    The Joint Commission requirements are equal to the CLIA 
requirements at Sec.  493.801 through Sec.  493.865.

C. Subpart J--Facility Administration for Nonwaived Testing

    The Joint Commission requirements are equal to the CLIA 
requirements at Sec.  493.1100 through Sec.  493.1105.

D. Subpart K--Quality System for Nonwaived Testing

    The Joint Commission requirements are equal to or more stringent 
than the CLIA requirements at Sec.  493.1200 through Sec.  493.1299. 
For instance, the Joint Commission has control procedure requirements 
for all waived complexity testing performed.

E. Subpart M--Personnel for Nonwaived Testing

    We have determined that Joint Commission requirements are equal to 
the CLIA requirements at Sec.  493.1403 through Sec.  493.1495 for 
laboratories that perform moderate and high complexity testing.

F. Subpart Q--Inspections

    We have determined that the Joint Commission requirements are equal 
to the CLIA requirements at Sec.  493.1771 through Sec.  493.1780.

G. Subpart R--Enforcement Procedures

    The Joint Commission meets the requirements of subpart R to the 
extent that it applies to accreditation organizations. The Joint 
Commission policy sets forth the actions the organization takes when 
laboratories it accredits do not comply with its requirements and 
standards for accreditation. When appropriate, the Joint Commission 
will deny, suspend, or revoke accreditation in a laboratory accredited 
by the Joint Commission and report that action to CMS within 30 days. 
The Joint Commission also provides an appeals process for laboratories 
that have had accreditation denied, suspended, or revoked.
    We have determined that the Joint Commission laboratory enforcement 
and appeal policies are equal to or more stringent than the 
requirements of part 493 subpart R as they apply to accreditation 
organizations.

IV. Federal Validation Inspections and Continuing Oversight

    The Federal validation inspections of laboratories accredited by 
the Joint Commission may be conducted on a representative sample basis 
or in response to substantial allegations of noncompliance (that is, 
complaint inspections). The outcome of those validation inspections, 
performed by CMS or our agents, or the State survey agencies, will be 
our principal means for verifying that the laboratories accredited by 
the Joint Commission remain in compliance with CLIA requirements. This 
Federal monitoring is an ongoing process.

V. Removal of Approval as an Accrediting Organization

    Our regulations provide that we may rescind the approval of an 
accreditation organization, such as that of the Joint Commission, for 
cause, before the end of the effective date of approval. If we 
determine that the Joint Commission has failed to adopt, maintain and 
enforce requirements that are equal to, or more stringent than, the 
CLIA requirements, or that systemic problems exist in its monitoring, 
inspection or enforcement processes, we may impose a probationary 
period, not to exceed 1 year, in which the Joint Commission would be 
allowed to address any identified issues. Should the Joint Commission 
be unable to address the identified issues within that timeframe, we 
may, in accordance with the applicable regulations, revoke the Joint 
Commission's deeming authority under CLIA.
    Should circumstances result in our withdrawal of the Joint 
Commission's approval, we will publish a notice in the Federal Register 
explaining the basis for removing its approval.

VI. Collection of Information Requirements

    This notice does not impose any information collection and record 
keeping requirements subject to the Paperwork Reduction Act (PRA). 
Consequently, it does not need to be reviewed by the Office of 
Management and Budget (OMB) under the authority of the PRA. The 
requirements associated with the accreditation process for clinical 
laboratories under the CLIA program, codified in 42 CFR part 493 
subpart E, are currently approved by OMB under OMB approval number 
0938-0686.

VII. Executive Order 12866 Statement

    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

    Authority: Section 353 of the Public Health Service Act (42 
U.S.C. 263a).

[[Page 31361]]

    Dated: May 18, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-12639 Filed 5-24-12; 8:45 am]
BILLING CODE 4120-01-P
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